Statistical fragility of outcomes in acellular dermal matrix literature: A systematic review of randomized controlled trials

Abstract

BackgroundAcellular dermal matrix (ADM) is commonly utilized in plastic and reconstructive surgery (PRS). With the abundance of randomized controlled trials (RCTs) reporting P-values for ADM outcomes, this study uses the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical stability of outcomes in ADM RCTs. MethodsPubMed, Embase, SCOPUS, Medline, and Cochrane databases were reviewed for ADM RCTs (2003-present) reporting a dichotomous, categorical outcome. FI and rFI (event reversals influencing outcome significance) and FQ (standardized fragility) were calculated and reported as median (IQR). Subgroup analysis was performed based on intervention types. ResultsOut of 127 studies screened, 56 RCTs with 579 outcomes were included. The median FI stood at 4 (3 - 5) and FQ was 0.04 (0.03 - 0.07). Only 101 outcomes were statistically significant with a median FI of 3 (1 - 6) and FQ of 0.04 (0.02 - 0.08). The nonsignificant outcomes had a median FI of 4 (3 - 5) and FQ of 0.04 (0.03 - 0.07). Notably, 26% of outcomes had a number of patients lost to follow up equal to or surpassing the FI. By intervention type, the median FIs showed minor fluctuations but remained low. ConclusionsOutcomes from ADM-related RCTs are statistically fragile. Slight outcome reversals or maintaining patient follow-up can alter the significance of results. Therefore, future researchers are recommended to jointly report FI, FQ, and P-values to offer a comprehensive view of the robustness in ADM literature.